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Comment on the Environmental Protection Agency (EPA) Proposed Rule, which is misnamed “Strengthening Transparency in Regulatory Science” by May 18, 2020. Related information, Open Docket Folder and comment here: https://www.regulations.gov/docket?D=EPA-HQ-OA-2018-0259

Comment submitted by Ronnie Levin et al., Department of Environmental Health, Harvard School of Public Health

We appreciate the opportunity to provide comments on EPA’s supplemental notice of proposed rulemaking, “Strengthening Transparency in Regulatory Science”.

We submitted comments opposing the initial proposal in 2018, along with the International Society for Environmental Epidemiology, the National Academies of Sciences, the American Lung Association, the American Association for the Advancement of the Sciences, and other leading public health, medical and scientific organizations.

To date, EPA has yet to respond to those comments or engage with these affected stakeholders. EPA’s supplemental proposal does not address the substantive scientific, technical and legal issues raised in the earlier public comments and the original problems with the rule remain. The lack of response alone compromises EPA’s reputation as an honest broker in its regulatory work.

We were surprised to see that the supplemental proposal expands the scope of the rule to cover all scientific data, which could include, “environmental fate studies, bioaccumulation data, water-solubility studies, environmental fate models, engineering models, data on environmental releases, exposure estimates, quantitative structure activity relationship data, and environmental studies.”

This will eliminate many scientific studies from EPA’s consideration — studies underlying the National Ambient Air Quality Standards under the Clean Air Act, the Lead and Copper (Drinking Water) Rule under the Safe Drinking Water Act, the Hazard Standards for Lead in Paint Dust and Soil under the Toxic Substances Control Act, indeed all of EPA’s proposed or finalized rules.

EPA has long set the highest scientific standards within the federal government, emulated and adopted by other federal, state and local agencies. Two of us developed EPA’s cost-benefit analysis in 1985 that supported EPA’s 90% reduction in the allowable amount of lead in gasoline. That analysis, touted by economists and public health officials and researchers and even by OMB at the time, set the mold and methods for hundreds of subsequent cost-benefit analyses not only in the US but globally. EPA’s reputation for state-of-the-art health and economics research is being severely damaged by this proposal.

Elsewhere, EPA itself has stated that “Whether research data are fully available to the public or available to researchers through other means does not affect the validity of the scientific conclusions from peer-reviewed research publications.” As scientists and health professionals, we strongly value open science which includes data sharing and full reporting of methods-but this supplemental proposal would not improve data sharing, replicability, or transparency in decision-making, as described below.

Furthermore, EPA’s choice of when to pursue this rulemaking — while the nation is grappling with the worst pandemic the US has faced in over 100 years, is highly inappropriate. EPA is facing numerous requests to postpone hearings and extend public comment deadlines currently.

This proposed rule would limit the use of critical scientific information in the middle of a public health crisis, constraining EPA’s (and the rest of the US government’s) ability to utilize the “best available science,” and “adequate information,” which, in this case, could have fatal consequences. It would force EPA to exclude “high quality” studies based on an availability criteria that has no scientific justification.

In short, we oppose this regulation and recommend its immediate withdrawal.
We submit detailed comments addressing the following issues.
1.Withdrawal of the proposal.
2.Lack of compliance with executive orders 12291, 13045, and 12898, requiring benefit-cost, children’s environmental health risks or environmental justice analyses to support the rule.
3.EPA has expanded the scope of the rulemaking in two important ways that will undermine the use of science in decision making:
a.Expanded the type of data to which the rule would apply, changing from dose-response data to all environment and health related data
b.Expanded the scope of types of EPA products to which this would apply from pivotal regulatory decisions to include influential scientific information.
4.Limiting the use of the best science available could result in many deaths related to the immediate covid-19 pandemic as well as suspension of compliance with other existing air pollution rules.

We appreciate the opportunity to provide public input. Please do not hesitate to contact us with any questions regarding these comments.


Ronnie Levin, Harvard School of Public Health, Department of Environmental Health
Joel Schwartz, Harvard School of Public Health, Department of Environmental Health
Jahred Liddie, Harvard School of Public Health, Department of Environmental Health

Attachment: https://www.regulations.gov/contentStreamer?documentId=EPA-HQ-OA-2018-0259-11183&attachmentNumber=1&contentType=pdf
ID: EPA-HQ-OA-2018-0259-11183
Tracking Number: 1k4-9gke-pn27
Document Information
Date Posted:
May 14, 2020
https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-11183 Emphasis our own.

Information-comments from the earlier comment period two years ago: